Common use of Regulatory Matters, Etc Clause in Contracts

Regulatory Matters, Etc. There occurs any of the following: (i) the FDA or any other Regulatory Authority initiates an enforcement action against, or issues a warning letter with respect to, any Loan Party or any of their respective Subsidiaries, any Product or any manufacturing facilities for any Product that causes any Loan Party or any of their respective Subsidiaries to discontinue or withdraw, or would reasonably be expected to cause any Loan Party to discontinue or withdraw, marketing or sales of any Product that has generated or is expected to generate at least $250,000 in revenue for the Loan Parties and their respective Subsidiaries on a consolidated basis over any period of twelve (12) consecutive months, or causes a delay in the manufacture or sale of any such Product, which discontinuance or delay would reasonably be expected to last for more than thirty (30) days, (ii) a recall of any Product that has generated or is expected to generate at least $250,000 in revenue for the Loan Parties and their respective Subsidiaries on a consolidated basis over any period of twelve (12) consecutive months or (iii) any Loan Party enters into a settlement agreement with the FDA or any other Regulatory Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, in excess of $250,000; or

Regulatory Matters, Etc. There occurs any of the following: (i) the FDA or any other Regulatory Authority initiates an enforcement action against, or issues a warning letter with respect to, any Loan Party or any of their respective Subsidiaries, any Product or any manufacturing facilities for any Product that causes any Loan Party or any of their respective Subsidiaries to discontinue or withdraw, or would reasonably be expected to cause any Loan Party to discontinue or withdraw, marketing or sales of any Product that has generated or is expected to generate at least $250,000 1,000,000 in revenue for the Loan Parties and their respective Subsidiaries on a consolidated basis over any period of twelve (12) consecutive months, or causes a delay in the manufacture or sale of any such Product, which discontinuance or delay would reasonably be expected to last for more than thirty (30) days, (ii) a recall of any Product that has generated or is expected to generate at least $250,000 1,000,000 in revenue for the Loan Parties and their respective Subsidiaries on a consolidated basis over any period of twelve (12) consecutive months or (iii) any Loan Party enters into a settlement agreement with the FDA or any other Regulatory Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, in excess of $250,0001,000,000; oror (p) Material Adverse Effect. There occurs any circumstance or circumstances that could reasonably be expected, either individually or in the aggregate, to have a Material Adverse Effect. 113 CHAR1\1707916v5

Regulatory Matters, Etc. There occurs any of the following: (i) the FDA or any other Regulatory Authority initiates an enforcement action against, or issues a warning letter with respect to, any Loan Party or any of their respective Subsidiaries, any Product or any manufacturing facilities for any Product that causes any Loan Party or any of their respective Subsidiaries to discontinue or withdraw, or would reasonably be expected to cause any Loan Party to discontinue or withdraw, marketing or sales of any Product that has generated or is expected to generate at least $250,000 1,000,000 in revenue for the Loan Parties and their respective Subsidiaries on a consolidated basis over any period of twelve (12) consecutive months, or causes a delay in the manufacture or sale of any such Product, which discontinuance or delay would reasonably be expected to last for more than thirty (30) days, (ii) a recall of any Product that has generated or is expected to generate at least $250,000 1,000,000 in revenue for the Loan Parties and their respective Subsidiaries on a consolidated basis over any period of twelve (12) consecutive months or (iii) any Loan Party enters into a settlement agreement with the FDA or any other Regulatory Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, in excess of $250,0001,000,000; oror (p) Material Adverse Effect. There occurs any circumstance or circumstances that could reasonably be expected, either individually or in the aggregate, to have a Material Adverse Effect. 9.02